Observational Safety Study of Enbrel for Treatment of Psoriasis - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00322439

Purpose

This is an observational safety study tracking psoriasis subjects on Enbrel for 5 years.

Condition	Intervention
Psoriasis	Drug: etanercept Drug: Enbrel

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis

Further study details as provided by Amgen:

Primary Outcome Measures:

Assess long-term safety of participating subjects, determine incidence rates of Serious Adverse Events (SAEs) and Serious Infectious Events (SIEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate incidence rates of Events of Medical Interests (EMIs) for participating subjects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Whether rates of SAEs, SIEs, and EMIs differ according to (a) prior exposure to systemic therapies or phototherapy, (b) exposure to Enbrel therapy, and (c) presence of certain co-morbid disorders [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Patient- and physician- reported outcomes and healthcare resource use over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, serum, plasma.

Enrollment:	2520
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Observation Those subjects with plaque psoriasis	Drug: etanercept Subjects will receive at least one dose of prescribed etanercept as per prescribing information for the treatment of plaque psoriasis Drug: Enbrel Subjects will receive at least one dose of prescribed Enbrel (etanercept) as per prescribing information for the treatment of plaque psoriasis

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.

Criteria

Inclusion Criteria:

Patients with plaque psoriasis

Exclusion Criteria:

Prior exposure to any TNF-inhibitor
Subjects for whom Enbrel is contraindicated
Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322439

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040210
Study First Received:	May 5, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00322439
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

plaque Psoriasis patients
TNF-inhibitor naïve

Study placed in the following topic categories:

Skin Diseases
Psoriasis
TNFR-Fc fusion protein
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009